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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, manipulator/injector, uterine
510(k) Number K772230
Device Name CANNULA, PERFUSION, FALLOPIAN TUBE
Applicant
J. SKLAR MFG. CO., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
J. SKLAR MFG. CO., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.4530
Classification Product Code
LKF  
Date Received12/06/1977
Decision Date 01/03/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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